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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name abutment, implant, dental, endosseous
510(k) Number K120338
Device Name ATLANTIS IN ZIRCONIA FOR DENTSPLY ANKYLOS IMPLANT, ATLANTIS LATER ABUTMENT IN ZIRCONIA
Original Applicant
ASTRA TECH INC.
8944 tamaroa terrace
skokie,  IL  60076
Original Contact b a brown
Regulation Number872.3630
Classification Product Code
NHA  
Date Received02/03/2012
Decision Date 07/05/2012
Decision substantially equivalent (SE)
Classification Advisory Committee Dental
Review Advisory Committee Dental
summary summary
Type Traditional
Reviewed by Third Party No
Expedited Review No
Combination Product No
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